HackED! How do you successfully implement a software solution

- I think we're definitely in for a treat. Why don't I kick us off and then if people wanna introduce themselves in the chat, feel free to do that. Otherwise, we'll get started. So as y'all have seen, this is our lovely speaker for today, Dr. Liz Clayborne. We're super lucky to be hearing from her given her background as both an ED physician, as faculty member at University of Maryland and very importantly for us today, she's also the CEO and Co-founder of NasaClip. The device that we were kind of previewing in our chat ahead of time, but we'll be hearing more about later today. This is a medical device for nosebleeds and in the process she's raised over 3.5 million in funding, was awarded an NSF SBIR phase one grant for the development of this device and has also been featured in all sorts of national venues to talk about her experience across the board in medicine as well as a Black female founder. And so we're super lucky to learn from her today and I'll let her take it away.

- Thanks Alice, really appreciate it. Very excited to be with you guys today, and just give you some pearls from, you know, the bumpy, convoluted road of being a CEO and co-founder of a medical device startup. And I do think that the space of hardware is a very different space than a lot of other like startups, especially tech like everyone kind of thinks of startups with tech and the challenges that you face when you have a hardware product are very different and you know, usually have huge impacts on your fundraising concerns, your like go to market strategy, how you commercialize and then things that you have to take into consideration as you are actually starting to get out into the market and build your commercial success. So I'll share screen so you guys can be walked through a little bit of what my experience has been like and then I certainly will leave some time at the end for you guys to ask any questions that you might have. So as Alice mentioned, I'm the CEO and co-founder of NasaClip, which is a medical device for treating nosebleeds, specifically anterior epistaxis. And today we're gonna talk about scaling a hardware solution. And you know, I really feel like this is gonna be helpful for not just hardware innovators because I do think that some of the things we have challenges within hardware are challenges for all founders. But I think when you're scaling a hardware, you see some of the commercial challenges upfront because you are required to take so many methodic steps in order to get your product to market that sometimes founders won't experience until they're actually in market and getting consumer feedback, a lot of times you stumble upon a lot of problems that you have to solve upfront. So I think it'll be helpful to everybody. So I will use the NasaClip story as like the foundation for talking about scaling up and then talk about how that might be applicable to other technologies. So for me, I'm an ER doc and you know if you ask any ER physician, they will tell you that nosebleeds and epistaxis is one of their favorite problems to deal with in the ER slash one of the most annoying things that we handle. It is like it blew my mind when I was in residency the number of people who showed up for nose bleeds. I was just like, why are you in this ER for a nose bleed? Like just put pressure on your nose. And what you'll find out is that most people do almost the opposite of what they're supposed to do to treat a nose bleed. They put their head back instead of forward. they pinch on their nasal bridge, not down here and they don't hold constant pressure, which is the most important thing. You need 10 to 20 minutes of uninterrupted pressure to stop a nosebleed. Sounds simple. Nobody does that. Like even you know, really strong grown men are only pinching their nose and letting go after about 30 seconds. So I think what happens is because epistaxis is bimodal distributed, most common in kids, two to 10, older adults, 55 to 80 who are often on blood thinners, they panic when they can't get the bleeding to stop and so they show up to the ER. But for us this is a lower acuity problem. And so it's not like, you know, you're having a heart attack or you just got shot so you often have to wait. And the problem for me was we didn't have anything to give them while they waited. They're just sitting up bleeding all over the waiting room, you know, bothering our triage nurse. So I was taught as a resident to take two tongue depressors and tape them together. And so I think I was in the middle of doing this and I'm like why am I having to like MacGyver together tongue depressors for a clip, like there should be a device for this. And so that is how for me the idea of NasaClip was born and you'll see the real device here, but when I first thought of it, it was just an idea in my head, right? It was like I think there should be a device that applies external pressure and probably has some kind of sponge or something to deploy medication in the nose because I know those are like the mainstays of how I treat epistaxis as an ER doc. But I wanted it to be easy to use, OTC and something that can be applied in any environment so that these people can stop coming to the emergency department. So NasaClip is that ER physician designed drug delivery device meaning that it helps to deploy the hemostatic and vasoconstrictive agents inside the nose and then has adjustable external pressure sized for children and adults. And so what I'm gonna start with is the end product in all of its glory and then I will backtrack into how we got to what you're gonna see now, which is our how to video of what the device looks like. So I'll show you quickly how it works just so you can see the mechanics. So it has these sponges here. This is a medical grade open cell sponge and it is designed to carry like a liquid medication like Oxymetazoline or Afrin. And if you a patient was having a nose bleed, you simply have them clear their nose of clot, insert the nasal sponge, rotate it into place, and pitch shut, just like that upholds firm constant unerupted pressure. And when you squeeze it applies internal pressure over Kiesselbach's Plexus, which is the source of most anterior nose bleeds. And then it also baths the nasal mucosa with the medication and keeps it there. But now the patient can relax because their mouth's clear, their eyes are clear, you can even mask them and sit them back out to the waiting room. You leave it a place to to 20 minutes and then simply release and then check for bleeding and it can actually be rinsed and reinserted. So that is how it works. That is what is in market now. This took me, you know, technically I thought of the idea in 2015 but you know didn't really pursue it until 2020. So I'll say it took me about four years to get from like something that was in my head to a actual product that you could buy on NasaClip.com and I'll show you what kind of our final marketing looks like. Whether you are a healthcare professional treating patients, a parent helping your child or a nosebleed sufferer seeking a solution, here's how to use NasaClip for quick relief. Your NasaClip arrives in packaging like this with individually wrapped NasaClips inside. NasaClip comes in both adult and pediatric sizes. The boxes are color coded for sizing. The adult size fits ages 14 plus and the child size fits most kids age two to 13. Those are my two daughters featured in all of our NasaClip media. In which case they may be removed from the device by un-snapping them from the wire. To begin, simply remove one of the NasaClips and open the sealed pouch. You may add medication to the sponges if directed by a healthcare professional before inserting the device. If you are assisting someone else or if you are inserting the NasaClip yourself, the following steps are the same. Step one, bend the head forward and below forcefully to clear the nose of any clots. Step two, pull apart pinch pads and rotate them away from the sponges to make it easy to insert both NasaClip sponges into the nostrils with the curve pointing upwards. Step three, rotate the clip into place and firmly squeeze shut over the nostrils. Step four, leave the device in place for 10 to 20 minutes. Step five, release the clip and check for bleeding. If bleeding persists, rinse the sponges with clean water, squeeze dry and reinsert until bleeding has stopped. Please seek medical assistance for nosebleeds lasting longer than 30 minutes. Each NasaClip can be used for one nosebleed episode. Please visit us at NasaClip.com for more information. So that's the final product, right? And so you know, if we back up, I initially had an idea in my head and I had to take it through the iteration of building a device, making sure that it worked, figuring out how to commercialize it so I could manufacture at scale, package and then introduce it to market. And there's a lot of steps that are involved there and so a lot of times I will have residents or people who have ideas, right, similar to me like oh you know, like I have an idea for this but I don't know where to start. And so when I look at what I did in my journey, the first step I think that you should take when you have an idea is to make sure you have a novel idea. You wanna make sure that you actually are not starting to like, you know, sink a whole bunch of blood, sweat and tears into something that has a really saturated market or you know, you're not really actually truly innovating in. So you wanna do a patent search and also look at you know, your competitive market. Patent searches like real ones cost money. And so it will come up really clearly as soon as you start any endeavor that it's gonna cost you some money. But you certainly can do, you know, some initial searches, see what exists on the market, see what the hospital space has, look in catalogs, look online and you wanna have a good understanding of the landscape. If you have what looks like a novel idea, the second thing I think is most important to do is to protect your intellectual property. So you know, when I first had my idea, I actually entered it into the GW business plan competition where I was a resident at the time and I was gonna be publicly talking about this idea. And so before I did that I made sure that I filed my provisional patent. If you talk about your idea in a public space, you can put your IP at risk. So you just wanna be careful when you're doing that. And then if you are talking to people who you know you're hoping to work with on the development of your idea, you wanna make sure you're having them sign NDAs and kind of like getting the legal paperwork under control, there are utility and design patents that are available. I filed for both but in the beginning, especially for like a medical device or a hardware device, a utility patent is like the most important. That's what has the most teeth. I just filed in the US to start with. But then as you extend your business, you will look at international options. So usually what they'll encourage you to do is file a PCT, which gives you broad coverage in a specific amount of time that allows you to use that US patent and then go into other countries within a certain timeframe. I believe it's 18 months to file patents in other countries. It gives you like that protection. So those would be the first two steps. And then after that, because I think those are the things that are most time sensitive, before you start really working on something, you really also wanna pause and make sure, do I have a good product market fit? I mean a lot of times something might make sense to you and you may love it and I think particularly as physicians, sometimes we get really attached to our babies and it's hard for us to hear like maybe your baby is not that cute or you know, maybe your baby's not gonna make it that far. And so you wanna do your diligence to make sure that you're vetting a market so that when you build this thing that you have in your head, somebody's gonna pay money for it. You know, like otherwise it's probably not gonna be that successful. And so part of the way that I did that is I was fortunately at GW through the kind of ecosystem with my advisor, Dr. Neil Sika who was my attending at the time at GW and the GW business plan competition to the I-Corps program. So there's the National Science Foundation which has a national I-Corps program and I participated in that like the year I founded my company. And they also have local I-Corps programs that are kind of nodes and geographic locations. And what they'll do is this provides you some grant money, you know, somewhere along the lines of for the national one $50,000 and it's all focused on making sure you do customer interviews and that you actually are going out into the market. And so we talk to trainers, coaches, you know, physicians, nurses, pharmacists, nursing home agencies and we ask them like how do you deal with nosebleeds? What is your protocol? What equipment do you use? If you had an option that looked or did this, would that be of interest for you? How much would you pay for it? So you can collect a lot of data and make sure that again, before you're pouring a lot of materials, money, effort and time and your life into this thing that you think is a great idea, you've vetted that you do have a pretty strong product market fit. And I think that's an essential step before you start down the path of like trying to actually make something physical that you can then show people, I was successful at this time. I mean I had nothing, I had nothing physical in my hands. I was really kind of trying to describe to them what it would do. And we did initially have some rudimentary drawings from our provisional patents. So there were like some images of what I thought it looked like but I didn't have any physical device when I did this and it's not necessary. You just really need to be able to show some kind of drawing or image of what it looks like and the way that you would like it to function in order to do this kind of work. And then from that standpoint, I would say that you also then need to like pressure test the idea. Meaning you need to do a more extensive exploration of like how your business is gonna function and there's a lot of different opportunities to do that. For me, I started with pitch competitions and business plans and they really made me dig into a market analysis. There are a number of accelerator programs of course that are gonna make you look at your entire business plan so that you understand like what are all the components that are gonna make me a successful company that is going to be able to fully commercialize and be profitable one day. And this will very clearly illustrate where you have holes. Like for me I was, you know, a resident at the time and then when I really started the fundraising in 2020, I was an attending physician focused on an academic emergency medicine career. I had no business background, I had no idea necessarily how to run a company, that said, I don't necessarily think it's not doable, right? Like I often heard people say like oh you're gonna have to get a CEO, you know, they'll never let you run your own company. You're gonna bring in you know, a C-suite that will run the company and you're only gonna be chief medical officer. That's not necessarily true. I don't think that that's necessarily true, but you do need to know where you have gaps in knowledge and where you need help. And for me, obviously I didn't have a strong business background so I had to learn a lot of that stuff. And then I also had a supplement on my team. Fortunately for me I had a co-founder Ramil Patel who's actually an undergrad in GW at the time in biomedical engineering and then went on to graduate school to get his master's in engineering along with his MBA and he ended up actually scaling up several other companies and has been a perfect co-founder for me to compliment, you know, kind of the gaps in knowledge I had from the business side and now serves as our CFO. And then we had obviously a lot of other things that I didn't know. And so I did these programs like you know, accelerator programs and pitch competition so that I could get into a network that could give me the executive management tools, the advisors that could tell me how I build a business and then start looking at who I was gonna, you know, bring onto my team part-time and eventually full-time where I really needed that help. But you first need to do an analysis of like what do I think this business is gonna run? How do I think it's gonna function? Who's gonna buy it? What's my plan for you know, us to actually manufacture, scale and then you know, sell it and what are the pieces that are needed to get from where I am right now to where I want to go? So for NasaClip in particular, I was aware and one of the things they're gonna have you explore in the business plan is that I was aware I had a big market, right? Because nosebleeds are really common, right? I made this for the pain point that exists for me as an ER physician. So obviously there's a big need in hospitals and urgent cares, but there were other big channels, schools and sports medicine were another one, right? Every school nurse deals with this all the time and we knew this from our customer discovery and what we found out is they actually just sit there and pinch a kid's nose. Like that's usually what they're doing and they're like one school nurse for hundreds of kids and they hated it. So they love this. Same with sports medicine, anywhere from you know, the coach of the little league to a professional trainer, we talked to the Wizards trainer in DC and he's like, yeah if I have a high value athlete that is like off the court because of a nosebleed, I need a device that gets them back into the game. So they would be willing to pay like a lot of money for that. So it was also available. And then we knew from our market research, that a third of US households had at least one member with chronic recurrent nosebleeds. There was also a big DCC opportunity for our device and that, you know, we really looked at it as being the bandaid of nosebleeds and wanting to make it like a ubiquitous medical product that would be in every kind of first aid kit, medicine cabinet for those people who had chronic bleed or kids that bleed all the time or you know, a parent on warfarin who's constantly getting nose leads so they could be prepared and not have to seek medical assistance. So you wanna know your market size and then on top of that you wanna know how you're going to go to market. And the reason this is important to understand is because when you're building the device, you need to understand who you're building the device for and how the iterations might be different depending on your, you know, customer segment that you're focused on and where your beachhead market exists. For us, we decided after a lot of customer discovery that focusing on B2B markets first was gonna be crucial to us being successful because when we talk to consumers and ask them how do you know how to treat a nosebleed, the majority of them said, well either like, you know, a doctor told me to do this or a nurse or a trusted family member. So the majority of them were getting the information about how to treat nosebleeds from a medical professional. So we wanted to establish ourselves in the medical profession as that go-to solution for nosebleed emergencies and then it would actually serve as a stepping stone to the consumer market that was less knowledgeable and would require a lot of marketing and education to make them aware that that solution existed. So we knew we were gonna focus on B2B and we probably knew that we were, we were gonna focus probably on the beachhead that I created it for, right? Hospitals and ERs because that's where we thought the pain point was the highest. And obviously hospitals had the resources to buy something at a reasonable price because they knew that this was a problem. That wall was lower acuity required a lot of time and resources to take care of in an environment like the ER where we're really resource poor and really stretched to the max all the time. There were also what we call our in-between medical direct segments, which were kind of like the sports and schools as well as travel and event medicine. So these are like cruises, airlines, large events, parks, camps, pools in addition to you know, the schools and sports medicine, anywhere where there's like large groups and there might not be that much medical personnel or people who are not really well trained. Nobody likes blood, right? Nobody wants blood around other folks. And so they probably needed that solution and that was another way to kind of get into a B2B market. So that was gonna be our secondary focus and then we would move into a consumer focus after we've had a little bit of traction in these first two segments. So now that we had a good understanding of like who our customer was, what pain points we were treating for them, what the kind of consumer archetype looked like that we were segmenting, then we start, I started looking at like okay, so how am I gonna build this device and how I'm gonna make sure that it functions well for the people that I want to have it? And so for me it's helpful if you have some kind of model or an example or an analogous thing that you could give to a designer engineering firm so that they could start working on it. So what I did is I knew that I wanted a clip that had external pressure because I felt that patients that were using like nasal tamponade devices or things that went in the nose and expanded, they hated that like it's super uncomfortable, patients don't tolerate it well, it's painful and it's really considered more invasive. So I wanted something that was more first line nose bleed rescue but just provide a good external pressure that can be, you know, easily tolerated by an older adult or a younger kid. 'Cause I knew those were the demographics that most commonly bled. And so I recognized that there was a kayak clip which kayakers used for to prevent water from going up their nose and I bought some of them and I basically brought that to my engineering firm and I said hey, like I kind of want it to look like this, an external clip that looks a little bit like this and applies pressure but starts like in an open position, you can control how much pressure you're applying so it's customized and then it has these sponges that go inside. So part of it was me talking them through what I wanted and part of it was me kind of giving them examples. A lot of people asked me like how I found my engineering firms. I utilized at the time the ecosystem I had at University of Maryland where I'm now a faculty member. They had an Office of Technology Transfer, OTT, and also just a few resources within their startup community. And so I initially worked with a company called Route 3 Wraps, that did the very beginning iterations of device and I'm remiss, I'm sorry, I have a picture of like the very rudimentary first versions of the device, if I can find it on my phone, I will upload it to the presentations so you guys can see the sequence of how it looked like. We first did 3D printing and then we did, you know, putting, you know, taping it together and looking at different materials and there was this iterative process. I will say that you know, there's probably a number of engineering firms that you can work with. It's nice if you can use one that you've been referred to right, that someone else has used and you know that they could build something that you're, you're interested in or you've talked to somebody who's like had success with them, you being able to get you a physical product that came out of you know their head. You wanna make sure that you have an agreement with them where you're protecting your IP, right? 'Cause they're gonna be building this. But really the whole goal is that they would still be assigning that intellectual property of whatever that final design of your device looks like back to your company. And so you, you just gotta keep track of that because you cannot fundraise if you lose control of your IP. And then you also, when you're asking them to design need to make sure that they're being mindful of the sourcing. So what materials are they using, where are those materials gonna come from? How is there gonna be redundancy in your sourcing pipeline? These are things that are gonna be important so that you can scale a product in the future. And if you don't think about it early, you'll get something that maybe looks great and works great but maybe like I'll show you uses a very rare aluminum iron alloy mix that I cannot find anywhere in the United States and has to come from China that you know, got completely shut down during COVID and like was disastrous. So like these are things that you know, that were not even on my radar that became very real to me. So thinking about redundancy and your sourcing pipeline is and when they're actually designing is really important as far as like how common is this material? Where can I get it from, how expensive is it gonna be and are there multiple people who can provide it to me? And then usually they'll start with like 3D printing and then go through this iterative process. And what I mean by iterative is they just like piece together stuff like our first devices and I'm so sorry I meant to like look up this picture earlier today. I'm sure I could find it at the end when you guys are asking questions. Our first devices were like, you know, little pieces of what looked like almost paper clips with plastic like taped on them and glued on them just trying to get the form together. And then we kind of kept moving on from there. They did look at the kayak clip and the way that the kayak clip was made is it had a wire that was dipped in a kind of silicone rubber and so we started with a device that actually looks really similar to that. And so our first device is this aluminum iron alloy mix that was overmolded with silicone, and then this piece is a injection molded plastic piece that looped on our medical grade foam. And so each component of this was, you know, a challenge to come up with. Like I had to find a wire that held, you know, enough pressure where when I put it together, it held pressure but it wasn't so stiff that a older person or a kid you know couldn't pinch it together. But it also needed to hold enough strength. Then we had to make sure that this clipped onto the wire and rotated enough so that like when you put it in the nose, it could fit anyone's nose. I was really particular about the sponge 'cause I didn't want sponges being lodged in someone's nose and not being able to come off. So this first device was actually designed with a sponge that is actually one piece like this, and so now you're not at a risk for it coming off in the nose. And the sponge for me was one of the hardest iterative processes for us to figure out. Like I initially thought you could just mold a sponge 'cause they have sponges in all these different shapes, right? You could just mold a sponge and make a sponge that's perfectly kind of cone shaped for the nose. No, as it turns out, because I'm now on expert in medical grade foam, any kind of sponge that is like three dimensionally molded has a petroleum base and it literally smells like gasoline. So I had all these manufacturers sending me samples and they're like yeah this is a medical grade foam, you can put it in the nose. I'm like I know but like did you put it in your nose because it literally smells like gasoline. Like I can't put this in somebody's nose and expect them to keep it there. So we had to completely pivot from that idea of it being molded to what this is. This is like a specific kind of open cell PTU foam and it can only be stamped so it can't actually be three dimensionally molded. It's just like a sheet that you can stamp pieces into. So the engineering team had to kind of engineer around like okay well how are we gonna do that so that it still loads onto the device and they were able to come up with a solution. And I'm really happy with this foam though because like the foam does what I want, it's actually really soft, does not irritate the mucosa, can hold the volume of medication that I thought I needed. And that was really through a lot of trial and error. I'm just doing a presentation right now. Gimme one second. Sorry guys, I'm in a working space. Okay, thank you. And so really going through these iterative processes are time consuming and can be expensive. So you also have to be mindful of that and what kind of bandwidth you have. So for me and when we look at our product innovation roadmap, the first device I had you know that we brought to market is a class one 510K exempt device, which was very nice meaning from a regulatory standpoint, we did not have any regulatory hurdles to get to market. Which was another thing that is really important to understand is like what is your regulatory pathway to commercialization? If you have a device that is gonna require extensive clinical trials, those are all things that have to be built into your business plan and your fundraising objectives and it's probably gonna be a much longer path. For me, I wanted from the beginning to have the device medicated and I thought it'd be cool to have it pre-medicated but as it turns out, it's way better to not have the device medicated because I was able to get my FDA registration and I'm so sorry I had no idea they're gonna start cleaning in here while I have, you guys can hear me okay? Okay great. So having an idea of like what's gonna be required from a regulatory standpoint is really important. We decided to introduce the device unmedicated both so that physicians could have the utility to add whatever medication they might prefer to the sponges. So maybe they wanna Afrin or maybe they wanna you know, reach for TXA or something more potent and they could do that. But more importantly it meant that I could get to market right away, which means I could start generating revenue right away, which means that that builds a lot more pathway for me to be able to get the device off the ground and build enough momentum that I can fundraise later for these other iterations. So these next iteration of the device that we're looking at is a class two device that would be medicated with an Oxymetazoline. And I didn't know this but Afrin or Oxymetazoline is technically off label for treatment of epistaxis. So I cannot publicly tell patients on our website for example to use Afrin for nosebleeds even though it is our standard of care. It's written our textbooks as like what you were supposed to do to treat a nose bleed. But you know, good to know because you do not wanna get in trouble with the FDA. And so for us to change the indication for Afrin, we would literally have to go back to the FDA and apply for them to change the OTC label. So I've done things as far as like contacting Bayer who makes Afrin and P&G who makes Vick's Sinus and be like, hey why don't you guys change this OTC label to include, you know, treatment of epistaxis because there's a big market for this. They're like, well we know it's you know, routinely used off label so we just never have done it. Doesn't help me, but like good to know. So what we have decided to circumvent that is that you can do a convenience kit where you kind of keep both things on label and you can say the Afrin is used for shrinkage of mucus membranes, which is helpful in the setting of nosebleeds and package those together. So that's like next iteration. And then once I actually developed the device, I realized it was really good at delivering intranasal medications. And so I started thinking about like what would it mean if we looked at NasaClip as a drug delivery platform? And these are some of the things when you're developing a hardware that you might discover is that there are other innovations within your technology that may spin off that could potentially be even bigger or more important than your initial technology. The market for NasaClip as a drug delivery platform is how I plan to exit this as a billion dollar company. Like in my opinion, what I have seen is that a lot of times we're delivering say Narcan, right? Naloxone, opioid reversal agent, first responders, EMS, police are spraying Narcan up the nose a lot and as you know when you spray it a lot of that washes out. It doesn't actually get absorbed across the nasal mucosa, it's going into the posterior pharynx. It's not really staying there. And then because these drugs are so strong now people are having to be re dosed all the time. And so if you look at using NasaClip versus a nasal spray, now you're putting that medication on a sponge, putting it up the nose and putting that system under pressure. I believe it'll be a more effective way to deliver intranasal medications with potentially even less medication. And so that would be not only applicable to Narcan but like benzodiazepines for seizure and anxiety, analgesic meds, allergy meds, you know even our vaccines right now, right? That we're delivering intranasally. And so that's my series A play and these are things that I'm thinking about. They'll have to be an entire overhaul of our device to optimize it as a drug delivery platform versus an epistaxis device. But because I've thought about this early, we're looking at you know, non-diluted funds with grants for example from NIH to really look at you know, can we get a commercialization of NasaClip now that's focused more on this drug delivery platform? And this is something I literally stumbled into, just came up with in the process of my iterative design process for NasaClip as a nosebleed treatment device. So fundraising, I wanna spend a little time talking about this 'cause I know it's not the focus of this talk but like you need money for everything. And so part of what your challenge with hardware is to understand how much money do you need 'cause that's what they're gonna ask you. And it is really hard to gauge how much money sometimes you need for a hardware because it always takes longer and requires more resources than you may think. There are just a lot of unforeseen delays even now I'm gonna talk to you guys about our new version of the device that's launching and I've had so many delays and so many design snags that have caused us to spend more time and money than I've wanted. But you do need to have, you know, some source of capital and that's gonna become really evident as early as like, you know, trying to get your patents done which can be really expensive. So for what I did in particular is I did a pre-seed raise that was focused really family and friends and then moved into my seed raise that I'm currently in which is a $4 million raise. So I did pre-seed of 1.1 million, seed of 4 million, which I'm is a mix of angel and venture capital money. And then I did obviously also look at our non dilutional funds, which would be our SBIR grants and different government programs. And then the other category that you can always look at is debt instruments. But usually those require you to be in market and have some kind of revenue minimum, although not always. There's more programs that are available for those now. Sorry, there is also a bug in here. I'm having like the, the funnest time in this booth, the most fun time I should say. But debt instruments can fund things like inventory which are much more important to consider for a hardware, right? Like these are things where you're talking, you're talking about you're dropping a lot of money on running a production line of say 50,000 units and you don't wanna always use capital that's coming from investors for that. It's nice if you can use instruments that are not gonna be diluting your equity in your company. So as I mentioned what I did is a pre-seed raise of two pre-seed raise of $550,000 each. And honestly shout out to my fellow docs. I was heavily supported by basically fellow physicians in my pre-seed grades. It was like a lot of my EM friends, pediatricians, ENTs who were like, yeah like I think that's a good idea. And we had a $5,000 minimum check and I was able to raise, you know, basically that first million dollars from friends and family and a few angel groups. And that is what allowed me to get to the point that I was actually able to launch the first version of my device on the market. I also got that first non-dilutive grant of 256,000 and we used that to primarily focus on optimization of the pediatric size of the device 'cause I knew I needed a peds and an adult size and so it was nice that we had that. Plus it gives you nice notoriety I think to have government grants. So I always encourage people to pursue non-dilutive grant funding whenever they can. And then what we're in the middle of now is our seed raise. This is an equity based raise of $4 million which we're using to basically accelerate ourselves of the class one version of the device. And we're introducing a new reusable version of the device that's actually gonna be launching on Amazon in October of this year. And I've closed just over half of that 2.5 million and we're actually gonna be opening up a crowdfunding campaign for that later. So I'll have to give more information about that 'cause I have lots of thoughts about fundraising and I had misnomers about crowd fundraising and you know a lot of things that are I think changing in the landscape of med tech and especially hardware when you have a consumer facing device that makes crowdfunding actually a lot more applicable to companies that are in medical technology that has historically have not been. And I don't think it's gonna hurt my potential future fundraising efforts for series A. So market introduction, like one of the things I always wanted to bring up 'cause this was told to me, you are not gonna be happy with the first product that goes to market. Like most of us are perfectionists that are docs. And it really was hard for me to like say okay we're gonna, this is the one, like this is the thing we're introducing the market because I constantly had things like I want this better, I want that better, I wanna do this, I wanna do that. But you have to understand that like no successful company, right, introduced their best product and that was it. Most of them had this iteration right, where they had a preliminary concept, they got feedback from their customers and they went back and redesigned, redesigned and came to you know, a product that was better. And so to show you the example of that, I've shown you what the first device looked like, right? And it had this aluminum iron mix, silicone overmold, this injection plastic piece. And what we heard from both sports trainers and our consumers is like hey love your device but we keep wanting to reuse the clip. Like why can't you just make it so the sponges can be replaced? And I was like oh that's like a good idea, how can I do that? So I talked to my engineering team and so this is the new version of NasaClip and it basically has, this is an all injection molded device that's plastic on the bottom, silicone over mold. It's slides out like this, you still use the medical grade sponges, they still slide into the nose and now they slide into place like this and lock and they actually provides a tighter fit 'cause I was actually worried about the device not being tight enough for some noses and because it's lighter weight, now if I'm an athlete I could run around because this is much lighter than the heavy metal I was using. And that the big feature is that when you're done, you can release the clip and there's a release tab on the bottom here, you pull this apart, can pull the sponge off and now you can actually reload the sponge and have a new device and sorry, the same device that you're reusing the sponge for, which is great for our consumers and also helped us in the market where, you know, people on the consumer side were a little more price conscious, right? Hospitals had no issue with our price point but the consumer was a little bit like, oh we don't wanna have to reuse a new device every time we're having a nosebleed. So now this will be available on Amazon, this is what our new packaging looks like where you can buy a device in seven sponges for about 25 bucks, which is a lot more palatable than our original device, which is ranging from like, you know, 16.50 to 17.50 a unit. And we also had to just make sure we had good margins across the board for all of these product offerings. So part of what you'll look at when you're manufacturing is like all of the components of building a device is not just the device but it's the device, the packaging, the way that you ship it, like all of those things are costs that you have to take into consideration and then what you're gonna sell it for. So I'm showing you here to just show you what kind of margins might look like for a consumer device. So we will offer the device in a single use which are for kind of medical facilities. So a 20 pack, which is our medical pack, it comes in a twin pair so that you have a device that you actually use to stop the nose bleed. And we send a patient home with a take home device, which they love. It cuts back on the recidivism, it makes the patient happy. And it also for my ED, that has extraordinarily long wait times ensures they don't elope because I tell them I'm gonna give them a free device, they just need to come back and make sure they see me in 20 minutes so I can make sure their bleeding has stopped. And so for those devices you can see we sell a 20 pack for about 330, which is about 16.50 per unit or $33 for two and the reason we use that kind of price point is because nasal tamponade devices on average are 37 to $52 a unit. So it's less expensive than a rapid rhino for example, but can be applied by a nurse tech up in triage and use a lot less of your doc's time. And then on the 10 pack, that'd be more for like a school nurse or a coach or a trainer. And so you see what that price point is and then if you see at the reusable kit, now we're introducing something that has a device and seven sponges for closer to that $25 price point which is palatable for you know, a consumer. So these are things that you wanna consider and this is the redesign of our device that we did because I knew that the first thing we introduced wasn't gonna be perfect. And even with this one I have things that I've already been like, okay, I want this to be better, I want that to be better. You are never gonna feel 100% confident that it's the perfect thing to introduce. You have to pull the trigger at some point and you will learn things from the device being in the market or your hardware being in the market that you just cannot anticipate. And so unless you get out there, you won't learn it and you actually just wanna get out there and get more feedback. That said, I would be careful about the quantities that you produce, right? There's always gonna be a plus and minus about how much you know of the foam am I ordering, how much of all the components am my ordering because I might want changes. And so there are price breaks obviously when you scale up and you order 50,000 units and then order 500,000 units, that price point is gonna be different for you and your cogs will be affected by that. But there has to be a balance between not doing too much upfront inventory commitment because you know you're gonna have iterations and changes to your device. So that's the same thing to be mindful of. And then I showed here what our cogs look like so that you see what margins exist. Margins are really variable depending on the market and where you're in. If you're doing a really heavy kind of medical device market, you may not have margins that look like this. This is more of what is expected from a consumer margin, this like 65 to 75%. But we have really healthy margins. Investors love this, right? It does not cost that much. The other reason I redesigned this is it dropped my cogs from the first device by almost 50%. So it was like a win-win win, less expensive, works better and is reusable. I'm gonna wrap up here shortly 'cause I wanna make sure you guys have time for questions. Oh, actually that is the last one. So the last thing I wanted to finish with is just to, oops, make sure you guys have like ideas about where your vision for your product exists, right? For me, you know, I'm committed to building a billion dollar brand and I think that the NasaClip can be the bandaid of nosebleeds and I think, you know, technically the market size would not support a billion dollar exit, but I actually think that nosebleeds are common enough that we could get there just with the nosebleed, but obviously we will also be engaging in the drug delivery platform to get to those goals. But it was really clear to me that outside of myself and like, you know, the desire I had as a physician to just provide something that was more useful to my patients and to my fellow colleagues who were providing, you know, care for patients in the emergency department, I wanted something that was simple but elegant and you know, really made nosebleeds less scary and less time consuming. And I think that a legacy that I could see for a NasaClip is that it will be the bandaid of nosebleeds, right? When you think of nosebleeds, you'll think of NasaClip the way that everyone says bandaid and not bandage. And so I think, you know, sometimes you wanna step back and be like, where is the trajectory of where I'm going? What kind of impact do I want it to have? And where do I think that you know, this hardware or this device can live? And then the other thing that I really encourage people to think about is like, where is your founder and CEO mission? You know, I did not go into medicine thinking that I was gonna be a startup CEO and founder. I just simply saw a problem that I thought could be better solved and I came up with a solution for that. But it then introduced me to this entire experience of being someone who's fundraising, you know, in an environment where we only give 2% of venture capital to women. And you know, someone who's been very prominent in speaking on a national stage where you don't see that many women of color. And I'm really passionate about the fact that representation matters. And so for me, my mission as a CEO is to be an example that others can follow. So it's not just about getting NasaClip out there 'cause I think NasaClip is great. I think that my story is important as well because I think that other women and people of color will be able to say, hey, if she can do it, I could try this too, right? I have residents all the time who are like, okay, like maybe I can look at this, maybe I can come up with a way to get my idea to market. And I think that ultimately once I've exited, I'm really, you know, dedicated to the cause of being able to go back and invest in other women and people of color so that I can give them that early access to capital to get, you know, their dreams to fruition as well. So I'll stop there. I wanted to make sure I give time for questions. And then I do encourage any of you guys that have questions for me that are not on this particular call, you can email me here and then that is my cell phone number. And then obviously I will plug like if any of you guys want me to get NasaClip into your institutions, please by all means reach out to me because we are, you know, really focused on getting NasaClip everywhere. And I would love any introductions to medical directors or other healthcare organizations or event medicine, travel, all that that you think it could be useful for.

- That was amazing. Thank you so much Dr. Clayborne and truly an inspiration your whole journey. I see a bunch of questions in the chat that I can certainly read out, but I'd love the question askers to come off mute if they wanted to introduce themselves and ask the question. So Chris H. you're up first.

- Yeah, nice to meet you Dr. Clayborne, a really interesting talk and it's amazing to see the story transition. Yeah, I was just starting with the intellectual property question. So did GW's, I'm assuming that's George Washington?

- Yes.

- Yeah. Helped you with the intellectual property initial filings or was that something that you took on your own?

- Yeah, so at the time I was a resident, they did have me use the OTT firm, which was Blank Rome, to file my provisional patent. And what happened was I was fortunate that I was a resident because residents are technically paid through Medicare. So the actual institution like GW had no rights to my IP. If you are a faculty member and you do this, your academic institution will have rights and it does muddy the waters a little bit when you are trying to fundraise. So if at all possible, I think it's better when you can assign IP to your company. I just happened to be lucky. I had no idea that that was the rule. I just happened to be lucky that I came up with it as a resident. So when I filed the patent they were like, well she's a resident, like it's her patent, like it's gonna be assigned to her company. But if you come up with something while you're employed as a faculty member, the rules can be different and you're gonna have to be mindful of that. At the same time, when you are a faculty member and you come up with something, they do have a lot of resources to help push forward your, you know, your technology and can provide additional funding. So there's some benefits there as well.

- I didn't know about that either. That's really interesting. Thanks for sharing, that's great.

- Dave, you're up next.

- Hello.

- No, Dave, please go for it..

- Oh hi. Super nice to meet you and thank you so much for sharing all your insights. I was just wondering when it came to like finding your payers and figuring out your insurance reimbursement structure, how would you recommend approaching that? It's often hard to figure out a price point. So I'd love to hear more of your approach towards like working with insurers, figuring out reimbursement codes and things of that sort.

- Yeah, so a lot of times your regulatory consultant, in addition to providing you like a pathway to, you know, how you're gonna be able to get approved to use your medical device. A lot of times people in that field will also know a little bit about reimbursement. Interestingly, in the realm of epistaxis there is no pass through billing. So what I found out is that if someone is using a rapid rhino or a cautery stick, the hospital eats that cost, they get a flat fee reimbursement for the ICD 10 for Epistaxis. So there is no like billing which simplifies it for us, right? But then it's a harder sell 'cause sometimes we basically are selling to the hospital like, well you'll be able to recoup more of your reimbursement for, you know, treating this patient. 'Cause you still can use the same CPT code for, you know, and management of anterior epistasis simple, but you're not using as many resources. If you have a device that's going to be reimbursed, you 100% have to understand who's reimbursing that, what the approval process is gonna be and like how that affects the workflow of the clinician. And so it's important I would say, if you have something that's complicated in that space, that you have a really strong advisor or someone who's dedicated on your team to doing that. In some regards, if you get something that's like really well reimbursed, it can make your, you know, technology as well. I met another founder, a DC based founder who does for post mastectomy patients. She does like the molds for them to have to wear in their bra so that they still can, you know, without breast implants have normal appearing anatomy and she was able to get direct reimbursement straight after mastectomy attached to them. And it sets her whole business plan up because the insurance is gonna pay for it. So it's nothing that's coming outta the pocket for the patient. It's a much easier sell, right? Like, 'cause almost everyone is gonna want that initially after their surgery. So certainly need to know that for me. Fortunately it was something that didn't come into play.

- Thanks so much.

- No problem.

- Awesome, Dave, go on.

- Thanks for the great talk Dr. Clayborne. I was wondering when do you feel like you've reached diminishing returns in terms of your user interviews? Like for example, do you, let's say you've had five interviews in a row and you're hearing pretty much the same thing. Do you think okay, I've seem to have covered all the angles or is there like a specific number that you want to hit?

- Yeah, you know, I don't know if there's a number. The customer interviewing never ends though. Like even now, right? We interview with, now that we're in the market and initially I was interviewing mostly physicians and people in the medical space and we didn't come up with the version of the reusable device until we talked to more sports trainers. They were the ones who were like, we can't have metal in the game. So like the metal is like a complete like issue for us. Can you design around the metal? And then it was the consumer that's like, and we'd like to reuse it and I would not have known or thought about that if I hadn't, you know, started talking to different kinds of consumers. In the beginning when you do the I-Corp program, they're gonna have you do about a hundred customer interviews. And I think talking to a hundred people of, you know, varying backgrounds and varying customers is a good, you know, that's a solid amount of data. I think, you know, you could start with 25, you'll see patterns at 25, a hundred will be good. I think at this point I've probably done, you know, over 200 interviews and we continue to kind of collect data and then once you're in market, there's other ways to collect that data, right? We ask for consumer surveys in addition to testimonials and all of that information can be more organized than in the beginning when you're just like kinda cold calling people or calling friends or you know, whoever, I would get 25 first under your belt and then build towards a hundred to get a good pattern.

- Oh, I guess I could go again.

- Yeah, you had another.

- So let's say if you could go back in time, we've heard like a bunch of horror stories about you know, COVID stopping everything and then the design process. If you could go back in time, are there things you would've done differently? Something I'd like to hear about is for example, the design firm. Would you have pursued the design firm pathway again or would you try to develop this in-house, manufacturing out of the country versus inside the country? Just some like lessons you've learned.

- Yeah, so I've been happy with my experience with a design firm. When you have a startup, it's really important to keep your burn under control. And so anytime you bring on full-time hires like that is really risky. Both because the hire could not work out and there's a lot of resources dedicated to finding that person, training that person and then like having a part of their team. So you actually always wanna outsource as much as possible early on. And especially for things like engineering because there's a lot of tools and you know, stuff that they need to like do their iteration. So I certainly think using a design firm is helpful. I used Harbor Designs in Baltimore, Maryland. We actually have our offices in their facilities so I can keep an eye on things all the time 'cause they also are doing all of our assembly packaging in 3PL right now. We're gonna probably outgrow them shortly, but I would do that. The sourcing, so you know this device, the wire, the silicone overmold and the plastic piece all came from China. The current device, we actually still have this piece, the plastic injection piece and the silicon overmold coming from the same supplier in China. Having overseas suppliers for some medical devices is gonna have to happen. What I will say is it's nice if it's North America, like maybe you can get into Mexico or Central America where you're not dealing with shipping times and things that are gonna be so disrupted by something like a pandemic. I didn't like how volatile the geopolitical climate with China seems to always be. There's a lot of risk there. So my director of operations right now is working really hard on how can we move everything to US sourcing or at least North America sourcing or potentially like a country that's not China really. Like just something that's a little bit more stable. And I think that I would've paid more attention to that in the beginning. A lot of times people go to China first because it is always gonna be usually the cheapest. But you have to remember cheapest is not always easiest, right? Disruption is in your supply chain is expensive and you know, you not being able to complete designs or have all these other things is gonna cost money in the long run. So it's not always worth having things that are really cheap. We also talk to retailers who are very interested in US made products, Walmart for example. A lot of retailers that we're looking at, they like when you're manufactured in the United States. So there's some benefits also to looking at the opportunities to do that. And you know, where you can, you know, it's certainly worth doing that to, to have better control over quality. If you have a hardware that's like, you know, an intricate medical device, you also wanna make sure you have good quality, right? If you are dealing something that could have huge devastating consequences of patients, you wanna make sure you have an understanding of where your materials are coming from and what their quality is, what their inspection process is. And it's a lot harder to judge that when it's not in the United States or not coming from a country where you can keep a really close eye on it. I see David's question, is that the next one? You can tell me what's next. Is that the next one?

- Exactly, yeah.

- Yeah. So you know, the other thing I'll tell you is it, it is really challenging being a founder. So the reason it was on the back burner for a long time is because I thought of it as a resident. I graduated, I got married, I had two kids and I was a new faculty member so I didn't really work on it even though I thought of the idea in 2015, I didn't really work on it until 2020. And the reason it was 2020 is I did an accelerator program during my maternity leave 'cause you know, there's nothing to do when you just had a baby. But it was the only time that I could be full-time CEO. And so I did this maternity, I was like breastfeeding my newborn infant through this you know, accelerator program with Tedco, which is our Maryland state-based venture fund. And I got a lot of really good executive management support and that was like where I started doing my first fundraising. But you know, in the process of building this company, I have since gone through a divorce that I had to protect the company in. I mean I continue, I was working full-time up until April of 2023. So literally almost having two full-time jobs. I like a lot of people who are like, you're not a serious founder unless you're a full-time founder. I think that's bullshit. Like nobody can support themselves if they don't have a job. And for me my job was like helpful because I'm selling into medical institutions and as we know ER docs are not gonna talk to other ER docs that don't practice clinically. Like they're not gonna think I know anything that I'm talking about. So I will always maintain clinical practice. I still practice about once a week, I've maintained my academic affiliation 'cause it's actually helpful in many ways for the research. But it is difficult to balance, and I would say that you need to be mindful of your wellness. If you burn out, like your company won't make it. So you have to consider yourself the most important asset and build in place the support mechanisms you need to make sure that you're successful. If you wanna learn more about that, there's a podcast that I just like really love called Founders by David Sinra. He goes through biographies and autobiographies of really influential founders both historically and present. Anyone from like Henry Ford, Jeff Bezos, Michael Jordan, there's a few women in there of course. I'm sure he will do a founder podcast on me one day. But they talk a lot about that balance and it's important to have 'cause you also don't wanna lose sight of what's most important in your life while you're doing this.

- Yeah, that's really good advice. Next one, Dr. Chanel Wagbo.

- You said that name perfectly well. Hey, Dr. Liz, my name is Chanel Wagbo. I just wanna say that this device is so innovative and I'm so happy I can't wait to get my hands on it 'cause I have a five-year-old son that bleeds every single day. Every day.

- Oh really?

- [Chanel] Yes he does.

- Well I'll give you a special discount code then, so NasaClip.com, first 50, F-I-R-S-T 50. 50% off for you or anyone else listening.

- Thank you so much.

- No problem. I would love to hear how it works. So let me know.

- Awesome. My question is, I'm a new entrepreneur and I just started this space and I am wondering is this, when you are in this new developmental stage, is it right to start seeking investors in while you're starting this? Or do you think that bootstrapping as much as possible would be better until until you can bootstrap anymore?

- I would say that most founders are gonna say really try to not take money until you absolutely need money. But in hardware it is almost impossible not to take money. Like it just, it requires so many resources to get, you know, your device iterations and development. Unless you happen to have, you know, a nice nest egg that you can dig away at, it's going to be required. But I would try to delay and pace as much as you can do without taking money. And then when you do take money, you need to be mindful of what that money is. I think angel money upfront is better. Angels are gonna give you a little bit more leverage with, you know, their expectations. Sometimes they're mission driven. I have a lot of angels who invested in me because I'm a Black female founder. So you, I can happy to connect you to those networks for your, you know, technology because there's, you know, sometimes angel groups that are not just interested potentially in technology like we do medical device but they might be like we support female founders or we support Black founders or we support founders from this academic institution or from this region. And they sometimes can provide really good benefits as well because they'll be helpful but not hounding you the way that VC money is. When you take venture capital money, they straight up expect a 10X return and they wanna know how they're gonna make their money. So when you get into bed with them, you gotta understand what that is and understand that the clock really starts a little bit more briskly once you're in bed with venture capital money. And so that timing needs to be carefully considered.

- Awesome. Thank you so much.

- All right, and we are close on time. Why don't I give you the last comment.

- Oh perfect. Okay, I'll do the last comment. So I think today was amazing. I think you're this point I really, really enjoyed hearing about was the issue of leadership. I think putting yourself out there and sort of putting yourself on TV shows, podcast news as a person of color, as a woman of color, I think what it does is other than also inspiring other people to wanna be like you and say I can also shows that, oh, if these people are getting funded and they're doing well, maybe we should fund more of these people.

- Yes.

- So I think this opens up a lot of channels for us and we're very appreciative of what you do and this has been great.

- No problem. And then just special love to my EM community 'cause I so adore that I'm an emergency physician. I think we're such a special breed, but in particular, I've had several people tell me that physicians have four reputations as founders. I think it comes from the idea that they have God complexes and that they just don't take feedback well. But I had someone recently say, but emergency physicians are almost perfectly equipped to be a founder because you guys work in a chaotic environment, have to deal with a bunch of different people, never have enough resources, you know, deal with unforeseen problems all the time. Multitask. Like he actually was like, if I were to look at the kind of physician that would be the best innovator and founder, it would be an emergency physician. So I think because of that, that's why we actually tend to be innovative and have great ideas. But I don't believe in the mantra that you can't lead your own company. If you don't want to, that's one thing. But if you believe that you can learn what you need, you can 100% do it and probably can be the best person for the job.

- That's amazing. Thank you so much. And that's a perfect way to segue into our plug. So we have two events coming up end of September, we have the HackED innovation competition. It's gonna be a three-day hackathon at ACEP. We'll post the link in the chat. There will be software and hardware tracks. HackEDis also part of an innovation pavilion that we're running at the EMIC. So there will be a pitch competition during them for early stage startups. You could visit our LinkedIn page to be able to look up the registration links. They're also gonna be posted in the chat. This is for early stage companies that you can apply and get the chance to present in front of Physician Angels and VCs and potentially get some early stage funding. So with that, I'm gonna stop and hand it over to Alice.

- Yeah, thank you all for coming out today and thank you Dr. Clayborne for sharing your wisdom. I'm sure our participants are gonna benefit a lot from thinking about the things you shared today.

- No problem, my pleasure.

- Yeah. Thank you. And then I put the ACEP link in the Zoom chat for those of you who aren't yet linked into our hotpot event for the end of September and then had one more link.

- Yeah, re pasted Dr. Edelman's link, which you saw nicely about earlier.

- Amazing. All right, thank you everyone.